EP3143536B1 - Auskultationsdatenerfassung, kommunikation und auswertesystem mit mobilen einrichtungen - Google Patents

Auskultationsdatenerfassung, kommunikation und auswertesystem mit mobilen einrichtungen Download PDF

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Publication number
EP3143536B1
EP3143536B1 EP15732074.8A EP15732074A EP3143536B1 EP 3143536 B1 EP3143536 B1 EP 3143536B1 EP 15732074 A EP15732074 A EP 15732074A EP 3143536 B1 EP3143536 B1 EP 3143536B1
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Prior art keywords
data
frequency
sub
communication
phases
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French (fr)
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EP3143536A1 (de
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Zeynep Yasemin Kahya
Ipek Sen
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Electrosalus Biyomedikal Sanayi Ve Ticaret AS
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Electrosalus Biyomedikal Sanayi Ve Ticaret AS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00—Instruments for auscultation
    • A61B7/02—Stethoscopes
    • A61B7/04—Electric stethoscopes
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation

Definitions

  • the present invention relates to an auscultation data acquisition, communication and evaluation system incorporating mobile facilities, comprising a chest piece for acquiring auscultation data and communicating said data in the form of a signal, a receiver unit and a distant server for communicating with said receiver unit and at least a further recipient relevantly selected from a list entailing suitable devices appropriated for use by healthcare personnel, medical facilities and users such that data and information are shared selectively in accordance with said recipients.
  • Electronic auscultation devices are gaining increasing popularity in medical industry. Some examples for them combine a stethoscope with an LCD screen and control buttons which can also record and communicate sounds to other devices for later evaluation by health professionals. Audio frequency responses of such devices are similar with acoustic stethoscopes. Their main advantage in comparison with acoustic stethoscopes is amplification ability for easier hearing of said sounds. Intelligent stethoscopes are not yet common, but considering a few patent applications on this subject, it is possible to expect such devices to be available in medical market.
  • WO 2013/089072 respectively US 2015/230751 (its English translation) relate to systems for acquisition, communication and evaluation of auscultation data.
  • US 2008 146 276 A1 discloses a device functioning in combination with a telephone, which compares digitized auscultation data with standardized disease sounds on a data storage unit integrated with said telephone, and a disease name appears on the telephone screen.
  • need for data storage units with sufficient capacities for storing great amounts of data, and requirement of powerful processors for performing sophisticated calculations and algorithms for probabilistic diagnosis limits the use of said idea with every smartphone.
  • the device disclosed in said application transmits only disease names to health professionals, which limits the health professional from using his/her own technical knowledge for reaching a decision by evaluations based on auscultation data.
  • International patent application WO 2011 049 293 discloses a device combining a stethoscope head with a mobile telephone.
  • the device acquires auscultation sound via a microphone head, and a disease name appears on the telephone screen.
  • Said device employs a temperature sensor which can serve for thermal checking whether the device is in proper contact with a subject's skin, yet such sensor which only aims to detect temperature is not suitable to distinguish whether said device is in contact with the proper body part or zone on a subject's skin to obtain meaningful auscultation data.
  • auscultation sounds have zone-specific characteristics both in healthy and pathological conditions, which fact necessitates the obligation to evaluate each collected sound data with regard to a corresponding database for each auscultation zone.
  • auscultation sounds are collected with regard to zones of auscultation, auscultation sounds are compared with a single database without regard to distinctions between zones.
  • a further important factor is taking into account the information about disease-specific auscultation sounds (e.g. crackles and wheezes) because the presence and characteristics of adventitious sounds are very important in determining the presence, type and severity of an underlying pathology.
  • disease-specific auscultation sounds e.g. crackles and wheezes
  • adventitious sounds e.g. crackles and wheezes
  • utilization of adventitious sounds in various phases of a respiration cycle in an algorithm which provides a probabilistic suggestion about medical state of a subject is not available in prior art.
  • US 6 648 820 B1 discloses a medical condition sensing system including a multiplicity of computers connected via a network, yet the vision related to said document is limited to acquisition and comparison of variable data obtained from a single patient at different instances. Said system and related method leads to designate initial data from patient as a baseline, and generates alerts in case of significant variations from the initial data. Evolution of initially present databases related to various health conditions, or creating new databases related to diseases which are initially absent in database collections are unachievable and underivable from such system.
  • US 2013/0102908 A1 discloses an air conduction sensor and a system and a method for monitoring health condition
  • US 5 218 969 A discloses an intelligent stethoscope for automatically diagnosing abnormalities
  • US 2014/0107515 A1 discloses a telemedical stethoscope which automatically diagnoses diseases, and records and stores data. None of these documents mention nor lead to evolution of initially present databases related to various health conditions, or creating new databases related to diseases which are initially absent in database collections.
  • US 5 218 969 discloses an intelligent stethoscope for automatically diagnosing abnormalities based on body sounds. Yet, said stethoscope lacks learning abilities since it can't enable the databases loaded thereon to evolve and nor create new databases related to diseases which are initially absent in its database collections. Furthermore, even though said document describes a method to obtain some diagnosis related to heart sounds; the chaotic nature of lung sounds renders said stethoscope inadequate for thorough and multidimensional handling of sound data for suggesting a probabilistic diagnosis.
  • Scientific research articles are available about computational analyses of auscultation sounds. Said articles generally discuss about acquisition of auscultation data, analog preprocessing i.e. filtration and amplification of said data, analog-to-digital conversion and transferring thereof to computers. Then, said data is subjected to analyses of spectral and temporal signal characteristics, detection and/or classification in terms of adventitious sounds (e.g. crackle and wheeze detection and/or classification), and classification in terms of conditions (e.g. healthy and pathological classification).
  • adventitious sounds e.g. crackle and wheeze detection and/or classification
  • classification in terms of conditions (e.g. healthy and pathological classification).
  • Primary object of the present invention is to provide a data acquisition, communication and evaluation system which overcomes abovementioned shortcomings of the prior art.
  • Another object of the present invention is to provide a data acquisition, communication and evaluation system which employs intelligent algorithms for providing health professionals and medical facilities (i.e. any location at which medicine is practiced regularly; for example, all health care institutions such as hospitals, health care centers, medical laboratories, research centers, etc.) with probabilistic evaluations of auscultation data.
  • health professionals and medical facilities i.e. any location at which medicine is practiced regularly; for example, all health care institutions such as hospitals, health care centers, medical laboratories, research centers, etc.
  • Another object of the present invention is to provide a data acquisition, communication and evaluation system which enables initially present databases related to various health conditions to evolve, and/or creates new databases related to diseases which are initially absent in database collections in said system.
  • an object of the present invention is to provide a data acquisition, communication and evaluation system which uses sound data both for computational and aural evaluation of auscultation data.
  • an object of the present invention is to provide data acquisition, communication and evaluation system which provides different levels of information obtained from auscultation data, the levels of which are suitable and meaningful for either medical facilities or healthcare personnel or users without medical training.
  • Yet another object of the present invention is to provide a data acquisition, communication and evaluation system, where auscultation data and any computations obtained from said data are simultaneously or subsequently available also to or from a location distant from the auscultation site.
  • a data acquisition, communication and evaluation system having a chest piece for fitting to human skin, a receiver unit and a distant server; wherein said chest piece encapsulates a sound transducer for acquiring raw sound data for being communicated in the form of a data signal; said receiver, in operation, is in communication with said chest piece; said receiver is a portable device having a display unit and data processing ability, and is further connectable to a local data network or global internet via wired or wireless communication interface; said distant server comprises computer coded instructions which, in operation, processes said data signals, stores medical information in association with said data signals and communicates said data signals and/or medical information with at least two recipients, wherein said at least two recipients are able to receive and send said data signals and/or said medical information, and wherein said at least two recipients are selected from the list consisting of devices held by healthcare personnel, medical facilities and users, said data signals and/or medical information are selective based on the selected recipient; the system, in operation, updates a computer-coded classifier as new data add to said database.
  • the present invention proposes a data acquisition, communication and evaluation system Figure 1 having a chest piece 100, a receiver unit 200 and a distant server 300; which system overcomes abovementioned shortcomings of the prior art as described below in detail.
  • said system includes a data acquisition device 150 which is an auscultation device with data communication abilities.
  • Said data acquisition device comprises a chest piece 100 and a receiver unit 200.
  • Said chest piece 100 encapsulates a sound transducer 101 for acquiring raw sound data for being communicated in the form of a data signal, wherein said sound transducer 101 is any kind of transducer which transduces (converts) vibratory mechanical oscillation (e.g., acoustic motion of a membrane) to an electrical signal (e.g., accelerometers, deformation piezoelectric transducers, microphones).
  • an electrical signal e.g., accelerometers, deformation piezoelectric transducers, microphones.
  • Said system further comprises computer(s) 400 preferably placed in (a) medical facility(ies), and said system further comprises a main (distant) server 300.
  • Said computers 400 are used for monitoring the data used in the system, for monitoring processed outcomes of said data, and for adding suitable information associated with said data to the system e.g. commentary information.
  • Said server 300 is for processing and storing data and arranging proper operation of said system with selective authorization.
  • said chest piece 100 is an air coupling non-metallic chest piece for comfortably fitting to human skin, said chest piece 100 encapsulates a microphone 101 for acquiring raw sound data for being communicated in form of a data signal.
  • Said chest piece 100 which is an air coupling unit can preferably provide a soft and non-cold touch to the skin by employing non-metallic material (e.g. polymers) for its parts contacting patient's skin, and provides preferably an ergonomic, comfortable grasp for user's hand. It preferably has a design for leaving an air coupling cavity 102 inside the chest piece 100 for proper operation of the air coupled microphone 101, while providing means for an air-tight contact of the chest piece 100 with patient's skin, thus preventing external noise.
  • non-metallic material e.g. polymers
  • Said receiver 200 is in communication with said chest piece 100, said receiver 200 having a display unit 201, and is a portable device with computing abilities, which can connect to a local data network or global internet 500 via wired or wireless communication interface.
  • a smart phone or a tablet computer or any such mobile unit can be employed as said receiver unit 200.
  • Said signal is a sound signal which can be used to estimate a form of air flow signal (see Figure 13 ) using mathematical algorithms e.g. a time-varying parametric model for predicting inspiration and expiration phases within a flow cycle such that sub-phases of inspiration and sub-phases of expiration can be predicted.
  • Said flow cycle is divided into sub-phases comprising early inspiration, mid inspiration, late inspiration, early expiration, mid expiration and late expiration.
  • said system in operation, estimates an air flow signal from said data signal using mathematical algorithms, predicts inspiration and expiration phases having sub-phases, within a flow cycle, and predicts sub-phases of inspiration and sub-phases of expiration (see Figure 13 ).
  • the system according to the present invention in operation, detects and computes
  • said system in operation, displays a plot of said signal in time domain with zooming and sliding capabilities, and said plot shows said sub-phases (see 2100 in Figure 12 ) and adventitious sounds comprising said detected crackles and wheezes.
  • the system according to the present invention in operation, generates and displays a frequency-domain representation with regard to each said zone and each said sub-phase, from which said system calculates and displays various parameters related to auscultation and makes comparisons of said parameters against related parameters obtained from healthy reference data, and displays (see 2200 in Figure 12 ) results of said comparisons.
  • said system displays a plot of said signal can preferably be displayed in time domain with zooming and sliding capabilities, for showing crackles, wheezes and said sub-phases (see 2100 in Figure 12 ).
  • a frequency-domain representation is obtained and displayed with regard to each zone and each sub-phase, from which various parameters related to auscultation are calculated, displayed and compared against those obtained from healthy reference data, the results of which are also displayed (see 2200 in Figure 12 ) in various formats.
  • the data acquisition, communication and evaluation system according to the present invention is provided with separate databases, each of said databases is related with a different respective pre-determined zone on human torso.
  • Said system further comprises a plurality of pre-defined data acquisition channels and/or data acquisition locations for evaluating data from each said zone and said system, in operation, generates directives for a user to place said chest piece at said pre-determined zones in accordance with a pre-determined sequence.
  • Spectral and temporal characteristics of said crackles having crackle frequencies in terms of fine, medium and coarse ranges, further having counts, and further having types are detected, computed and displayed in a time-frequency representation (see Figure 8 ), where time is expressed in terms of said sub-phases starting with early inspiration and ending with late expiration, and frequency is expressed in terms of fine, medium and coarse crackle frequency ranges.
  • Spectral and temporal characteristics of said wheezes comprising timing, at least one peak frequency component and a percentage of duration within said sub-phases, flow cycle, and a total auscultation period are detected, computed and displayed in a time-frequency representation (see Figure 9 ), where time is expressed in said sub-phases starting with early inspiration and ending with late expiration and where frequency is a continuous axis.
  • Said count of said types of crackles and wheezes are preferably mapped with regard to said zones for displaying with color codes and shape codes in regard with said zones (see Figure 10 and Figure 11 ) on a display.
  • the system according to the present invention further comprises a computer-coded classifier 313 in Figure 6 which, in operation, utilizes information from said frequency-domain representations (see 305 in Figure 6 ), and said time-frequency representations (see Figure 8 , Figure 9 , and 308 and 309 in Figure 6 ) for each zone and sub-phase, together with mathematical transforms, signal and system characterization methods, parametric models (see 310 in Figure 6 ), and - said computer-coded classifier 313, in operation, combines data and calculations for each zone and sub-phase, and generates a probabilistic health condition report with regard to said database.
  • a computer-coded classifier 313 in Figure 6 which, in operation, utilizes information from said frequency-domain representations (see 305 in Figure 6 ), and said time-frequency representations (see Figure 8 , Figure 9 , and 308 and 309 in Figure 6 ) for each zone and sub-phase, together with mathematical transforms, signal and system characterization methods, parametric models (see 310 in Figure 6 ), and -
  • the system in operation, updates said computer-coded classifier 313 as new data add to said database (see 354 in Figure 7 ).
  • said system provides probabilistic evaluations of auscultation data.
  • a data acquisition, communication and evaluation system which enables initially present databases related to various health conditions to evolve, and/or creates new databases related to diseases which are initially absent in database collections in said system, is provided.
  • the system further includes a distant server 300.
  • Said distant server 300 is a component for evaluation and storage of data and communication received from other components of the system i.e. the data acquisition device 150 and computer(s) 400.
  • Said distant server 300 comprises computer coded instructions which, in operation, processes said data signals, stores medical information in association with said data signals and communicates said data signals and/or medical information with at least two recipients, wherein said at least two recipients are selected from the list consisting of devices 200 and 400 held by healthcare personnel 11, medical facilities and users 10. Said recipients are able to receive and send said data signals and/or said medical information.
  • the distant server 300 is preferably the central component responsible for general coordination of the system.
  • the distant server 300 is for processing said data, for storing medical information based on and associated with said data and for communicating said data and information with at least two further recipients. Said data signals and/or medical information are selective based on the selected recipient.
  • the users can also be defined as normal users 10 without medical training and which perform auscultation; healthcare personnel 11 who uses the data acquisition device and associated computers in medical facilities, including nurses, physicians and other healthcare personnel; and other personnel responsible for proper operation of the system with or without medical training, who work in a medical facility, who are responsible for the coordination of health services associated with the system of the present invention, and who are assigned users of computers which are part of said system. It is envisioned that as processors used in mobile devices are more developed and have stronger capabilities, the facilities of the system may be contained in an application program.
  • information including data recorded from a subject and associated medical information which is selected from the list consisting of subject information, clinical subject data, algorithmic evaluation and outcomes from said system, and medical evaluation information provided by a healthcare personnel, are selectively accessible for users, such that respective data can be accessed by non-health-professional users 10 e.g. a patient, health professionals 11 making the auscultation or checking the data in a distant place, and employees of a medical facility providing access to said data through a server or computer which is a part of the system according to the present invention.
  • non-health-professional users 10 e.g. a patient, health professionals 11 making the auscultation or checking the data in a distant place, and employees of a medical facility providing access to said data through a server or computer which is a part of the system according to the present invention.
  • auscultation data and any computations obtained from the data are simultaneously or subsequently available also from a location distant from the auscultation site.
  • the communication and evaluation system tracks in time said probabilistic health condition and reports any changes in said probabilistic health condition or said parameters selectively for users, such that respective data can be accessed by health professionals, healthcare personnel and non-healthcare personnel users.
  • said system in operation, checks for proper auscultation (see Figure 5 ) by checking (i) whether said chest piece is placed correctly (e.g. by checking whether auscultation data meets the expected spectral characteristics special to a proper auscultation), and (ii) whether a subject inspires and expires properly such that sufficient air volumes for collecting data is inhaled and exhaled (e.g. by checking whether the air flow estimation algorithm works properly to estimate the air flow signal with expected inspiration and expiration behavior).
  • said system in operation, filters said signals according to a pre-defined frequency response shape including conventional bell and diaphragm modes, for listening by a user.
  • the chest piece 100 is preferably provided with one or more control switches 103 for enabling single-hand operation to turn said chest piece 100 on and off while holding it.
  • the chest piece 100 comprises (without limitation) following elements: an analog and digital signal processing circuitry 104 having amplifier(s) 1041, filter(s) 1042 and 1043, analog-to-digital converter(s) 1044, processor(s) 1045, a wireless transceiver 1046; and said chest piece 100 may further comprise a battery 105, control switches 103, status displaying LEDs 106, and a slot 107 for battery charging unit 108 plug.
  • Said wireless transceiver 1046 can work in any possible version of the Bluetooth protocol, or in any one of other wireless communication protocols.
  • Said battery 105 can be rechargeable through the charging slot 107, and during the charging, the operation of the device can be limited to prevent any risks with the electrical current.
  • the status of the battery and the charging process can be visualized through multiple LEDs with different colors, or with a single multi-colored LED 106.
  • the status of the Bluetooth connection between said chest piece and the receiver unit can also be visualized through multiple LEDs with different colors, or with a single multi-colored LED 106, or with one single-colored LED which is 'off' when disconnected, 'on' when connected, and 'blinking' when trying to establish a connection.
  • the chest piece 100 can be provided with a control switch 103 to turn on/off said piece 100 to save power during the time the device is unused.
  • Said control switch 103 can be a push-button, a slide, a toggle, a rocker, or any other suitable switch type.
  • the chest piece 100 can also be designed to go into a sleep mode if the receiver unit 200 does not send any command during a predefined interval of time.
  • the chest piece 100 can also be connected to the receiver unit 200 with a wired connection.
  • one or more components in the analog signal processing circuitry 104 of the chest piece 100 would not be necessary, but instead for example a standard 3.5 mm or other audio output port can replace said unnecessary components.
  • output signal of the chest piece 100 can be carried directly with a cable which is not necessarily in accordance with any audio standard, to an external analog/digital circuitry in connection with the receiver unit 200 through a brand-specific conventional connection e.g. micro USB or lightning.
  • receiver units 200 can employ receiver units 200 other than smart phones or tablet computers, where such receiver unit 200 includes a wireless radio transceiver (e.g. Bluetooth, Zigbee) for communicating with said chest piece 100, processor(s), a memory, a display screen 201 (preferably a touch screen), switch(es), a battery, a battery-charging slot, an application program 202, and wired (e.g. PLC, DSL, fiber) and wireless (e.g. 2G/3G cellular, GPRS, Wi-Fi, Wimax, LTE) communication capabilities for communicating with at least two further recipients other than said chest piece 100, including said distant server 300.
  • a wireless radio transceiver e.g. Bluetooth, Zigbee
  • processor(s) e.g. Bluetooth, Zigbee
  • a memory e.g., a memory
  • a display screen 201 preferably a touch screen
  • switch(es) e.g. PLC, DSL, fiber
  • wireless e.g.
  • the chest piece 100 of such embodiment is cable-connected to an external analog/digital circuitry 104
  • the connection between the analog/digital circuitry 104 to the receiver unit 200 can be made through a design-specific non-conventional connection type.
  • such external analog/digital circuitry 104 can also be integrated into the receiver unit 200, enabling the chest piece to be cable-connected directly to said receiver unit 200.
  • the chest piece 100 and the receiver unit 200 are combined in one casing, then the combined chest piece - receiver unit can be designed to connect directly to a local data network or global internet 500 via wired or wireless communication interface to communicate with other components of the system.
  • another embodiment according to the present invention combines the chest piece 100 and the receiver unit 200 while still using a smart phone or tablet computer as receiver unit 200, wherein the chest piece 100 is installable at the back of said receiver unit 200 as conventional phone/tablet dock-cases do.
  • auscultation is to be performed by contacting a side of the device with the microphone 101 onto chest wall of a subject being auscultated, while the display screen 201 of the device facing towards the user conducting the auscultation. Therefore, such embodiment would especially offer a useful design for accompanied-auscultations, e.g., those performed by an accompanying family member or by healthcare personnel.
  • an example for a typical operation of the preferred embodiment of the data acquisition (auscultation) device by the normal user is described as follows.
  • the user starts (see 2021 in Figure 4 ) an application program 202 on the receiver unit 200, and follows several graphical, written and vocal directives generated by said application program to ensure a proper data acquisition session. If it is a first-time use (see 2022), said directives may first lead the user to enter his/her name, surname, age, gender, and other useful information for identification, thus for creating a user account (see 2023).
  • Multiple users can be defined in such application program, e.g., members of a family can create accounts for themselves using the same device.
  • the user enters the application program 202 through his/her own account (see 2024), and several directives (see 2026) lead the user to turn on the chest piece 100 e.g. using a switch 103 (if it is 'off' at that instant), to enable a wireless connection e.g. a Bluetooth connection on receiver unit's side (if it is disabled at that instant), to wait for the connection to be established (if it is not already connected). Then, further directives (see 2027) lead the user to place the chest piece on a first auscultation location on the torso of a subject (e.g.
  • the application program 202 preferably waits for the user to press/switch/touch a Start button to start recording (see 2028), and then records auscultation sounds during a predefined time interval (see 2029). If the algorithm 2030 and Figure 5 detects that the chest piece is not air-tight with subject's skin, or, that the subject does not inhale and/or exhale properly (e.g.
  • the application program 202 preferably warns the user accordingly and stops recording (see 2031), to wait for the next start-prompt.
  • several directives lead the user to continue with a subsequent predefined auscultation zone on the subject's torso, following a predefined sequence with regard to several predefined zones on said torso, until the recording with the last zone in the sequence is successfully completed (see 2033).
  • the user is instructed or guided for a sequential auscultation of several predefined zones on a subject's torso, which sequence is to be used in combination with different sound databases associated with each predefined zone for comparison.
  • the user can listen (see 2034) to recorded sounds through a filter appropriately designed considering a normal user.
  • the application program 202 may ask additional questions (see 2035) to the user (other than those asked for account creation), such as weight, length, smoking habits, current complaints etc. of a current subject; which questions may require text or numeric inputs and/or multiple choice answers. If a user chooses to continue (see 2036 and 2037), the application program makes the receiver unit send all data 2038 to the distant server 300 to be evaluated.
  • the server 300 can verify the user type (see 301 in Figure 6 ), performs computations and evaluations, and sends relevant outcomes (those that are limited suitably for the normal user) back to the receiver unit.
  • the computations and evaluations performed in the server comprise flow signal estimation 302 from sound data, sub-phase division 303 such that the inspiration and expiration phases are divided into their early, mid and late portions (thus, six sub-phases in a full respiration cycle, three for inspiration and three for expiration), frequency domain transformations 304, calculation 305 of various spectral parameters and their comparison 306 with a healthy reference, crackle and wheeze detection 307, analysis 308 of detected crackles in terms of spectral and temporal characteristics such as their timing, class label (i.e.
  • the system according to the present invention in operation, displays
  • a classification sequence is proposed according to the present invention, which sequence uses a sophisticated combination of algorithms for adventitious and vesicular sound classification, merging decisions specific for each respiration phase in a full respiration cycle (e.g. early, mid and late phases for both inspiration and expiration in a full respiration cycle).
  • a decision merging algorithm for different respiration phases is combined with Bayesian decision methods on a parametric or generative model in disease classification (e.g. GMM), and further combined with a linear discriminative classifier in multidimensional projection space for auscultation sounds classification (e.g. SVM).
  • said system in operation, maps said detected crackles and wheezes with regard to said zones, and displays said detected crackles and wheezes with color codes and shape codes (see Figure 10 and Figure 11 ).
  • time-plots of recorded sounds are continuously updated and can be observed on a screen in real-time during recording (see 2029 in Figure 4 ).
  • Those time plots are to be updated (see 315 in Figure 6 ) with special colored marks, letters and waveforms for estimated flow sub-phases and detected crackles and wheezes after this information is computed in the distant server and sent back to said receiver unit (see 2100 in Figure 12 ).
  • Preferable written and vocal reports that a normal user 10 can be allowed to access may include, but are not limited to:
  • a user can access said outputs that he/she is authorized to access by pressing/touching/switching relevant buttons, or by activating associated tabs, and the like, in an application program 202 (in Figure 2 ).
  • All recorded data which are sent to said distant server, all outputs generated through computations and evaluations by distant server, and all other information associated with user are stored in the server, and are accessible by authorized components of the system according to the present invention, such as a main computer 400 (in Figure 1 ) in a medical facility that can be assigned to said user regionally, or a health professional 11 that said user 10 is a regular patient of.
  • Information can be appended in a line (see 351 in Figure 7 ) to be accessed and examined by a personnel who is responsible for dealing with said records.
  • the distant server (which may be considered as central component of the system according to the present invention) produces an alert message in a suitable form, and delivers said message to relevant medical facility and/or professional responsible from the user, from starting a quickest communication form e.g. a text-to-speech message over a phone call.
  • a user feels urgency (e.g., due to unbearable complaints), even by skipping sound recording (see 2025 in Figure 4 ), he/she can communicate (see 2039 in Figure 4 ) with a medical facility or professional through e-mail, SMS, call, or by any means that are technically possible at that moment.
  • the communication can include sharing generated reports with a medical facility or professional using the system according to the present invention, the type of said reports depends on compatibility with a suitable communication form.
  • said application program 202 (in Figure 1 ) on the receiver unit 200 (in Figure 2 ) also keeps a summary information in said unit's memory, including selected parameters from each auscultation-evaluation session, to keep a track of any evolution of the health condition of a subject over time using any previously evaluated parameters associated with that subject.
  • a user can access tracking information at any time by entering said application program and can see it in a graphical form and/or as a short, written report.
  • said information is preferably to be used in said server to update (see 355 in Figure 7 ) learning algorithms. Updating the learning algorithms provides the objective technical effect of evolution of initially present databases related to various health conditions, and furthermore creation of new databases related to diseases which are initially absent in database.
  • An application program 202 (in Figure 2 ) running on said receiver unit 200 (in Figure 1 ) can also receive any software updates sent through said distant server.
  • the system according to the present invention provides different levels of information obtained from auscultation data, levels of which are suitable and meaningful for either medical facilities, or healthcare personnel, or users without medical training.
  • the system according to the present invention records auscultation data in a broad frequency band such that any sound evaluation can be produced using calculations, and using said filters the system outputs a customary sound in a narrower frequency band for aural evaluation by health professionals.
  • said system uses and produces sound data both for computational and aural evaluation of auscultation data.
  • Typical operation of a preferred embodiment of a data acquisition (auscultation) device of a system according to the present invention would be generally the same in a general framework for the alternative embodiments of the device listed above, any differences being introduced due to appearance of said system but not its functionality.
  • the system according to the present invention is preferably modifiable and/or extendable, and/or expandable to record, send and process heart sounds in similar modes. Also other medical data such as blood pressure, SpO 2 , blood sugar, ECG may be incorporated into the system.

Claims (7)

  1. Ein Datenakquisitions-, Kommunikations- und Auswertungssystem, das ein Bruststück zum Anpassen an menschliche Haut sowie eine Empfängereinheit und einen entfernten Server aufweist, wobei:
    - das Bruststück einen Schallwandler zum Aufnehmen von rohen Tondaten enthält, die in Form eines Datensignals kommuniziert werden sollen,
    - der Empfänger im Betrieb mit dem Bruststück in Kommunikation steht,
    - der Empfänger ein mobiles Gerät ist, das eine Anzeigeeinheit und Datenverarbeitungsfähigkeiten aufweist und ferner mit einem lokalen Datennetzwerk oder globalen Internet über eine drahtgebundene oder drahtlose Kommunikationsschnittstelle verbunden werden kann,
    - der entfernte Server computerkodierte Befehle enthält, die im Betrieb die Datensignale verarbeiten, medizinische Information in Verbindung mit den Datensignalen speichert und diese Datensignale und/oder medizinische Information mit wenigstens zwei unterschiedlichen Empfängern kommuniziert, wobei die wenigstens zwei Empfänger konfiguriert sind, die Datensignale und/oder die medizinische Information zu empfangen und zu versenden, und wobei die wenigstens zwei Empfänger aus der Liste bestehend aus Geräten, die durch Gesundheitspersonal, medizinische Einrichtungen und Benutzer vorgehalten werden, ausgewählt werden, wobei Inhalte der Datensignale und/oder medizinischer Information bezüglich der jeweiligen Empfänger sich unterscheiden;
    - das System mit separaten Datenbanken ausgestattet ist, wobei jede der Datenbanken mit einer anderen jeweiligen vorbestimmten Zone auf einem menschlichen Torso in Bezug stehen;
    - das System eine Vielzahl vordefinierte Datenakquisitionskanäle und/oder Datenakquisitionsorte zum Auswerten von Daten aus jeder der vorbestimmten Zonen umfasst, und wobei das System im Betrieb Anweisungen für einen Benutzer erzeugt, um das Bruststück an den vorbestimmten Zonen gemäß einer vorbestimmten Sequenz zu platzieren;
    - das System im Betrieb ein Luftstromsignal des Datensignals unter Verwendung mathematischer Algorithmen abschätzt, Inspirations- und Expirationsphasen, die Subphasen innerhalb eines Stromzyklus aufweisen vorhersagt, und Subphasen der Inspiration und Subphasen der Expiration vorhersagt;
    - das System im Betrieb erkennt und berechnet:
    - spektrale und temporale Charakteristiken von Rasselgeräuschen, die Zeitablauf, Frequenzinhalt, Typen bezüglich feiner, mittlerer und grober Bereiche sowie Anzahlen umfassen, und
    - spektrale und temporale Charakteristiken von Pfeifgeräuschen, umfassend Zeitablauf, wenigstens eine Spitzenfrequenzkomponente und einen Prozentsatz einer Dauer zwischen den Subphasen von Inspiration und Expiration innerhalb Inspiration und Expiration innerhalb eines Stromzyklus und über eine totale Auskultationsperiode;
    - das System im Betrieb eine Frequenzbereichsdarstellung bezüglich jeder der Zonen und jeder Subphasen erzeugt und anzeigt, woraus das System verschiedene Parameter berechnet und anzeigt, die sich auf Auskultation beziehen, und Vergleiche der Parameter gegen entsprechende Parameter durchführt, die aus Gesundheitsreferenzdaten stammen, und Ergebnisse dieser Vergleiche anzeigt;
    - das System im Betrieb anzeigt:
    - die detektierten Rasselgeräusche mit Farbcodes und Formcodes in einer Zeit/Frequenzdarstellung, wobei Zeit in den Subphasen von Inspiration und Expiration ausgedrückt wird, und wobei Frequenz anhand feiner, mittlerer und grober Rasselgeräuschfrequenzbereiche ausgedrückt wird, und
    - die detektierten Pfeifgeräusche mit Farbcodes und Formcodes in einer Zeit/Frequenzdarstellung, wobei Zeit in den Subphasen von Inspiration und Expiration ausgedrückt wird, und wobei Frequenz eine kontinuierliche Achse ist;
    - das System einen computercodierten Klassifikator umfasst, der im Betrieb Informationen der Frequenzbereichsdarstellungen verwendet, und die Zeitbereichsdarstellungen für jede Zone und Subphase gemeinsam mit mathematischen Transformations-, Signal- und Systemcharakterisierungsverfahren und parametrischen Modellen verwendet wird, und
    - der computerkodierte Klassifikator im Betrieb Daten und Berechnungen für jede Zone und Subphase kombiniert und einen Gesundheitszustandswahrscheinlichkeitsbericht bezüglich einer jeweiligen Datenbank erzeugt; und
    - das System im Betrieb den computerkodierten Klassifikator als neue Daten der jeweiligen Datenbank hinzufügt.
  2. Datenakquisitions-, Kommunikations- und Auswertungssystem nach Anspruch 1, wobei das System im Betrieb einen Plot des Signals im Zeitbereich mit Zoom- und Verschiebungsfähigkeiten anzeigt, und der Plot die Subphasen und Nebengeräusche zeigt, die die detektierten Rasselgeräusche und Pfeifgeräusche umfassen.
  3. Datenakquisitions-, Kommunikations- und Auswertungssystem nach Anspruch 1, wobei das System im Betrieb die detektierten Rasselgeräusche und Pfeifgeräusche bezüglich der Zonen abbildet und die detektierten Rasselgeräusche und Pfeifgeräusche mit Farbcodes und Formcodes anzeigt.
  4. Datenakquisitions-, Kommunikations- und Auswertungssystem nach Anspruch 1, wobei Informationen, die Daten enthalten, die von einer Person aufgenommen wurden und mit medizinischer Information assoziiert sind, die aus der Liste bestehend aus Personeninformationen, klinischen Personendaten, algorithmischer Auswertung und Ergebnissen des Systems ausgewählt sind, und medizinische Auswertungsinformation, die durch Gesundheitspersonal bereitgestellt wird, zum Auswählen durch Benutzer zugreifbar sind, so dass jeweilige Daten durch nicht in der Gesundheit berufstätige Benutzer und in der Gesundheit Berufstätige zugegriffen werden kann.
  5. Datenakquisitions-, Kommunikations- und Auswertungssystem nach Anspruch 1, wobei das System im Betrieb korrekte Auskultation überprüft durch
    - Prüfen, ob das Bruststück korrekt platziert ist, und
    - Prüfen, ob eine Person richtig einatmet und ausatmet, so dass ausreichende Luftvolumina zum Sammeln von Daten inhaliert und aushaliert werden.
  6. Datenakquisitions-, Kommunikations- und Auswertungssystem nach Anspruch 1, wobei das System im Betrieb die Datensignale gemäß einer vordefinierten Frequenzantwortform filtert, einschließlich konventioneller Glocken- und Diaphragma-Modi.
  7. Datenakquisitions-, Kommunikations- und Auswertungssystem nach Anspruch 4, wobei das System im Betrieb die probabilistischen Gesundheitskonditionen zeitlich verfolgt und jegliche Änderungen in dem probabilistischen Gesundheitszustand oder den Parametern zum Auswählen durch Benutzer berichtet und jeweilige Daten an Gesundheitsberufsträger, in der Gesundheit Berufstätige und nicht in der Gesundheit berufstätige Nutzer bereitstellt.
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PCT/TR2015/000199 WO2015174944A1 (en) 2014-05-12 2015-05-12 Auscultation data acquisition, communication and evaluation system incorporating mobile facilities

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EP3143536A1 (de) 2017-03-22
WO2015174944A1 (en) 2015-11-19
US20170071565A1 (en) 2017-03-16
US10716533B2 (en) 2020-07-21
HUE046561T2 (hu) 2020-03-30
PL3143536T3 (pl) 2020-02-28
PT3143536T (pt) 2019-10-25
EP2945084A1 (de) 2015-11-18
ES2748669T3 (es) 2020-03-17
DK3143536T3 (da) 2019-10-07

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